This invention relates to a method and apparatus for ablating all or part of a human interior organ. More particularly, the invention relates to a device and method for performing a complete or partial prostatectomy of a diseased prostrate gland in the human male.
The need for treatment of the prostrate gland is important for several reasons. These include maintaining the patency of the prostatic urethra allowing for adequate urinary outflow, reducing urinary tract infections, treating hematuria, treating malignancy, and treating renal insufficiency. It is estimated that 50% of men over the age of 50 have some type of benign prostatic hyperplasia of the prostrate with that percentage increasing significantly with age.
There are numerous treatment methods well known in the art for the treatment of the prostrate gland which includes, but is not limited to: an open surgical method for direct access to the gland whereby the excision occurs retropubically or transperineally; a transurethral method whereby a device is inserted through the urethra followed by any number of treatment methods; and more recently, pharmacological agents that relax the smooth musculature of the prostate thereby reducing prostatic size.
One of the more common clinical methods of treating the prostrate is transurethral insertion of a device for access to the prostrate. Treatment and/or detection methods may include balloon dilation on a catheter, placement of permanent or temporary stents to stabilize the diameter of the urethra, cryotherapy, laser ablation or thermal therapy to reduce the size of the prostate, or heated wire loop or cutting edge used to cut away prostatic tissue. The disadvantages of the transurethral approach are damage to the urethral endothelium and severe patient discomfort.
In the open surgical retropubic method, an incision is made superior to the penis in the abdominal region to expose the bladder and the prostrate gland. The clinician subsequently removes all or a portion of the prostatic tissue by hand, cauterizes any bleeding vessels and passes a catheter through the urethra to temporarily drain urine from the bladder. This type of invasive surgery, generally requiring a hospital stay of several days, has many possible complications and is not used unless the prostrate gland has enlarged to an extent whereby transurethral or pharmacological agents would be difficult or have little systemic effect on the gland. Other surgical methods include the transrectal approach or a transperineal approach. In the transrectal method the prostrate is accessed through the rectal wall. The patient must be placed on antibiotics at least 24 hours prior to surgery to reduce any chance of post operative infection. Additionally, enemas should be given prior to surgery to eliminate any fecal matter that may be posited in the lower rectal cavity and be transmitted into the perineal cavity contaminating the procedure with enteric bacterial seeding. This approach has a higher degree of infection and traumatic complications such as hemorrhage or urinary retention than other methods.
The transperineal approach accesses the prostrate through the perineum and is not frequently used because of the difficulty in verifying the exact location of the treatment device within the prostrate. Additionally, rupture of the prostatic urethra and/or the rectal wall often has been a major problem during manipulation. Recently, an attempt has been made to decrease this blind manipulation by utilizing a rectal ultrasound probe to aid in the guidance of a marked needle through the perineal tissue. This procedure does not utilize direct vision and is time sensitive.
What has been needed yet heretofore unavailable is a safe and effective method to easily and cost effectively access the prostate gland so that it causes minimal trauma to the patient and yet still be effective and suitable. The present invention fulfills these needs.